Dilantin extended release 100mg capsulesNovember 8, 2002, Pfizer Canada Inc.
As you may be aware, Pfizer Canada has been recently experiencing a backorder situation, due to manufacturing difficulties, of its epileptic seizure medication, DILANTIN (extended phenytoin sodium capsules U.S.P.) 100 mg formulation.
In order to remedy this situation and to find a long-term supply solution for DILANTIN patients, Pfizer has worked to make DILANTIN 100 mg extended release capsules distributed in Canada meet a new U.S.P. (United States Pharmacopeia) dissolution specification known as Test 2. A dissolution specification refers to the rate at which a medication should dissolve in the body. This change in dissolution specifications is not expected to have a significant clinical impact on patients. However, as DILANTIN is a complex product and epilepsy is a delicate condition to treat, patients need to be advised of this change. As usual, any change in condition should be brought to the attention of your health care professional.
Health care professionals will be able to identify DILANTIN Test 2 product bottles by a bright yellow sticker stating "U.S.P. TEST 2". Product labels will be changed to reflect this information as soon as possible.
The next time you have your prescription filled at the pharmacy you may be given DILANTIN Test 2 product. Even though there is a change in U.S.P. dissolution specifications, dosing recommendations for DILANTIN 100 mg extended release capsules remain the same. It is important that you continue to take your DILANTIN as prescribed by your health care professional.
Please note that this change only applies to DILANTIN 100 mg extended release capsules and does not affect any other DILANTIN formulations such as DILANTIN extended release 30 mg capsules, DILANTIN suspension or DILANTIN Infatabs.
Pfizer is confident that this change in dissolution specification will result in a stable manufacturing solution for DILANTIN, and therefore, in a long-term stable supply situation for Canadian patients.
For further information, please contact your doctor and/or pharmacist.
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